TPLC - Total Product Life Cycle

• Device: accessories, operating-room, table (kit)
• Regulation Description: Manual operating table and accessories and manual operating chair and accessories.
• Product Code: FWZ
• Regulation Number: 878.4950
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	1
ALLEN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INAMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIC SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	8
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	1
THE ANSPACH EFFORT, INC.
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Device Issue	7
Defective component	6
Mechanical issue	5
Device operates differently than expected	4
Loose or intermittent connection	3
Markings unclear	2
Component falling	2
Tipover	2
Table, tilting	2
Other (for use when an appropriate device code cannot be identified)	2
Fracture	2
Positioning Issue	1
No code available	1
Device handling issue	1
Unknown (for use when the device problem is not known)	1
Unstable	1
Use of Device Issue	1
Component missing	1
Fail-safe design failure	1
Circuit Failure	1
Detachment of device component	1
Device remains activated	1
Slippage of device or device component	1
Total Device Problems	49

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	1	0	3	1	0	3	2
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Integra LifeSciences Corp.	II	Feb-21-2013
2	Integra LifeSciences Corporation	II	Dec-19-2012
3	Integra LifeSciences Corporation	II	Sep-09-2010
4	Integra Limited	II	Sep-26-2012
5	MAQUET Inc.	II	Jan-15-2009
6	Maquet Inc.	II	Jan-03-2013
7	Maquet Inc.	II	Dec-02-2009
8	Mizuho Orthopedic Systems Inc	II	Mar-13-2012
9	Orthopedic Systems Inc	II	May-04-2007
10	Sterilmed Inc	II	Jan-13-2009